Senior Manager, Regulatory Affairs & Quality Assurance

Bio-Techne empowers researchers in Life Science and Clinical Diagnostics by providing high-quality reagents, instruments, custom manufacturing, and testing services. Our family of brands creates a unique portfolio of products and services.  With the recent acquisitions of Asuragen and ExosomeDx, Bio-Techne has expanded its presence in the molecular diagnostics space. The combination of these businesses into a single Molecular Diagnostics Division provides a set of core capabilities and unique technologies ranging from biomarker discovery to international regulatory expertise and the ability to launch innovative products as both kitted products for international distribution as well as centralized laboratory developed tests.  This division unifies the processes of offering these capabilities and those of the broader Bio-Techne family of brands to pharma partners for projects ranging from biomarker discovery and assay development to full companion diagnostic development and commercialization.  

Position Summary:

The Senior Manager, Regulatory Affairs & Quality Assurance will lead a team of RA & QA professionals and work closely with internal colleagues to ensure compliance as we bring innovative products to a world-wide market. You’ll be a key member of the Regulatory Affairs and Quality Assurance team, supporting Asuragen as we continue to build on our vision that all people deserve better answers.

Key Responsibilities:

• Lead the high-functioning, service-oriented Quality Assurance and Regulatory Affairs teams at Asuragen.
• Mentor, guide, and provide development opportunities to direct reports.
• Identify and carry out activities to strengthen the compliance IQ across the company.
• Recommend and develop the regulatory strategies necessary to secure U.S. and international market approvals of Asuragen IVD products.
• Arrange, prepare for, and potentially lead meetings with FDA, International Agencies, Notified Bodies, etc. to establish agreed upon regulatory requirements for novel in vitro diagnostic devices and accessories.
• Develop overall timelines and plans by working with team members in research and development, QA, operations, and clinical affairs to ensure regulatory requirements are properly addressed and followed throughout product development plans. This is primarily achieved through Core Team membership.
• Prepare, file, and manage regulatory submissions for class II and III 510(k), de novo 510(k) and PMA medical devices (including Companion Diagnostics) in the U.S. Perform similar responsibilities for Technical Documentation Submissions in other regions including but not limited to Europe, the United Kingdom, and Canada.
• Coordinate with Asuragen’s distributor partners in regions where the distributor will hold the product registration, including preparation and review of product technical dossiers with partners, including Australia, Brazil, and Korea.
• Monitor global regulatory changes and report impact to Asuragen leaders during Quality Management Review meetings.
• Manage processes involved with maintaining annual licenses and registrations.
• Ensure compliance with product post-marketing approval requirements.
• Review and approve advertising and promotional items and publicly disseminated information to ensure regulatory compliance and preserve confidentiality of applicable product information.
• As needed, represent QA on cross-functional project core teams and internal project teams, providing guidance, addressing quality issues, and ensuring that project processes and documentation are complete, accurate, and finalized in a timely manner.
• Lead the management and continuous improvement of QMS processes, including Change Control, Supplier Management, NCR, Complaint Management and CAPA processes.
• Apply established risk-based approaches in accordance with BS ISO 14159:2019, EU 2017/746, and other applicable regulations and standards.
• Manage the conduct of internal and external Quality System audits to ensure that the sites operate in compliance with FDA/ISO/MDSAP/IVDR, and other regulatory bodies/quality standards as may be required and to remain “inspection ready” at all times.